Ototoxicity in patients with Metal-on-Metal hip Arthroplasties
Recruiting
- Conditions
- hearing lossototoxicity1001924310005944
- Registration Number
- NL-OMON56425
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
All MoM patients from the different clinics
Revision MoM
Willing to participate
Speak/write the Dutch language.
Exclusion Criteria
Not willing to participate
Previous ENT surgery or ENT pathology
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the prevalence of damage to the auditory system in patients with a<br /><br>Metal-on-Metal or revised Metal-on-Metal bearing, especially regarding mid<br /><br>frequency hearing loss. A distinction will be made between prevalence in<br /><br>patients with high plasma cobalt or chromium levels and patients with low<br /><br>plasma cobalt and chromium levels. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess which factors are associated with damage to the auditory system (We<br /><br>will only perform this if possible, if we have enough cases with hearing loss).<br /><br>o Factors of interest: highest known cobalt plasma concentration, highest known<br /><br>chromium plasma concentration, type of prosthesis, age, work in a noisy<br /><br>environment, presence of ARDM, revision<br /><br>o Patients will be asked to complete the hearing questionnaire as well as the<br /><br>Metal-on-Metal Prosthesis Questionnaire for Assessing General Health in order<br /><br>determine the general health of these patients and subjective hearing loss. </p><br>